Acute Lymphoblastic Leukemia, Adult B-Cell
Conditions
Keywords
Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance
Brief summary
Despite advances in the treatment of acute lymphoblastic leukemia, the prognosis in adults is still poor, largely due to the resistance of treatment at diagnosis or early relapse. Among the strategies associated with the treatment of Acute Lymphoblastic Leukemia is rehabilitation and physical medicine in order to improve the quality of life, body composition, fitness, strength and improve the attachment and acceptance of their treatment
Detailed description
Previous evidence had shown that among the beneficial effects of an exercise intervention in cancer is the reduction of adverse events associated with treatment, such as nausea and fatigue. Also, the overexpression of Interleukin-15 in cancer is related to a poor prognosis, biologically the implementation of a cross-training exercise routine can function as a regulatory pathway for its expression due to its consumption at muscular level. Finally, the time to consider a relapse with a very poor prognosis is during first three months of treatment, so implementation of an exercise strategy during this period could reduce the proportion of early relapses mediated by Interleukin-15 expression
Interventions
OTHERTraining
Training routine assigned by randomized chart
Sponsors
Hospital General de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The masking of the study will be for the principal investigator, only knowing the maneuver person in charge of the routine and the patient. The patients who will practice the exercise intervention will be carry out in certain space and time that does not interfere with the medical intervention and in which the treating medical personnel will not be present.
Intervention model description
Clinical randomized single blinded trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Ability to walk without support. * Life expectancy greater than 7 days * Previous authorization of treating hematologist for participation * Acceptance and signing of informed consent form
Exclusion criteria
* Patients with neutropenia, infections and / or bleeding on admission to hospitalization. * Patients that are unable to perform physical activity. * Central nervous system diseases that make movement impossible. * Cardiac function alterations assessed by electrocardiogram and echocardiogram * Patients in relapse * Patients referred from another hospital and who are been attended in our hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blasts in marrow | 3 months | Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle. |
| Neutrophils count | 3 months | Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle |
| Luekocytes count | 3 months | Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle |
| Platelets count | 3 months | Number of platelets found in peripheral blood at the end of each chemotherapy cycle |
| Hemoglobin count | 3 months | Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle |
| Functional Assessment of Cancer Therapy- Leukemia | 3 months | Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness. |
| Interleukin 15 | 3 months | Pro-inflammatory cytokine concentration, measured through peripheral blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admission to ICU | 3 months | Admission to ICU during the protocol |
| Hospital Stay | 1 month | Measurement of days of hospital stay |
| Hospital Discharge | 3 months | The event in which patient is dishcarge from Hopital stay, |
| Complications during hospital stay | 1 month | Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity. |
Countries
Mexico
Contacts
Primary ContactChristian O Ramos Peñafiel, PhD
Backup ContactAdan G Gallardo Rodriguez, MSc
Outcome results
None listed